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Eliminating Surgery After Systemic Therapy in Treating Patients With HER2 Positive or Triple Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02945579
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This clinical trial studies eliminating surgery and how well radiation therapy after systemic therapy works in treating patients with HER2 positive or triple negative breast cancer when image-guided biopsy shows no residual cancer. Patients then receive standard breast radiotherapy.

Condition or disease Intervention/treatment Phase
Estrogen Receptor Negative HER2 Positive Breast Carcinoma HER2/Neu Negative Invasive Breast Carcinoma Progesterone Receptor Negative Stage I Breast Cancer AJCC v7 Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage II Breast Cancer AJCC v6 and v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Triple-Negative Breast Carcinoma Radiation: External Beam Radiation Therapy Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Whole Breast Irradiation Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the 6 months (mo), 1, 2, 3, and 5-year biopsy confirmed ipsilateral breast tumor recurrence rate (IBTR, invasive, and/or in situ) among patients who do not undergo surgery.

SECONDARY OBJECTIVES:

I. To determine the number (%) of patients where final biopsy reveals residual disease and quantify the residual disease (residual cancer burden, RCB) determined by routine pathologic examination of surgery specimens.

II. To assess baseline, 6 months, 1, 3, and 5 years decisional comfort of clinical trial participation using the Decisional Regret Scale (DRS).

III. To determine patient-reported cosmetic outcome, breast pain, and functional status using the Breast Cancer Treatment Outcomes Scale (BCTOS) at baseline, 6 months, 1, 3, and 5 years.

IV. To determine the 6 mo, 1, 2, 3, and 5-year incidence of ipsilateral breast and nodal recommendation and performance of biopsy based on breast imaging follow-up.

V. Correlate "liquid biopsy" analyses (after neoadjuvant systemic therapy [NST], 6 months and one year postradiotherapy or surgery) among protocol participants with pathologic complete response (pCR), utilizing circulating tumor cells (CTCs) and circulating tumor-deoxyribonucleic acid (DNA) (ctDNA).

VI. Among patients who decide to proceed with routine surgery, record the results of final biopsy compared with routine pathologic examination of surgery specimens.

VII. To determine patient-reported quality of life using the Functional Assessment of Cancer Therapy-Breast version 4 (FACT B+4) instrument at baseline, 6 months, 1, 3, and 5 years after treatment.

OUTLINE:

Within 12 weeks of completing neoadjuvant systemic therapy, patients undergo whole breast irradiation over 15-25 fractions on consecutive days. Patients then undergo external beam radiation therapy (EBRT) boost over 7 fractions on consecutive days beginning the day following completion of whole breast irradiation.

After completion of study treatment, patients are followed up every 6 months for 5 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Trial for Eliminating Breast Cancer Surgery in Exceptional Responders With Neoadjuvant Systemic Therapy
Actual Study Start Date : January 20, 2017
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Treatment (whole breast irradiation, EBRT)
Within 12 weeks of completing neoadjuvant systemic therapy, patients undergo whole breast irradiation over 15-25 fractions on consecutive days. Patients then undergo EBRT boost over 7 fractions on consecutive days beginning the day following completion of whole breast irradiation.
Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Whole Breast Irradiation
Undergo whole breast irradiation




Primary Outcome Measures :
  1. Ipsilateral breast tumor recurrence-free survival (IBT-RFS) [ Time Frame: From confirmation of pathologic complete response (pCR) to the time of ipsilateral breast tumor recurrence or death, whichever occurs first or the time of last contact, assessed for up to 5 years ]
    Will monitor IBT-RFS using the method of Thall et al. Will be estimated using the Kaplan-Meier method log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.

  2. Overall survival [ Time Frame: Up to 5 years ]
    Will be estimated using the Kaplan-Meier method log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.


Other Outcome Measures:
  1. Change in biomarkers in blood and plasma [ Time Frame: Baseline, 6 months, 12 months ]
    Biomarkers in blood and plasma, specifically CTC and cDNA, will be assessed by exploratory data analysis and graphical methods, which will be applied to examine distributions and to identify data errors and outliers. Linear mixed effect models for repeated measures analysis will be employed to assess the change of the data over time with multi-covariates including disease characteristics (tumor stage, site, pathology), and other patient prognostic factors.

  2. Quality of Life measured by FACT-B+4 questionnaire [ Time Frame: Baseline, 6 months, 12 months, 36 months, 60 months ]
    The FACT-B+4 will assess the general quality of life of the patient.

  3. Quality of Life measured by BCTOS questionnaire [ Time Frame: Baseline, 6 months, 12 months, 36 months, 60 months ]
    The Breast Cancer Treatment Outcome Scale (BCTOS) will assess patient-reported cosmetic outcome, breast pain, and functional status by comparing the affected breast with her unaffected breast.

  4. Quality of Life measured by DRS questionnaire [ Time Frame: Baseline, 6 months, 12 months, 36 months, 60 months ]

    The Decisional Regret Scale (DRS) questionnaire will assess the decisional comfort of the clinical trial participant.

    Question answers range : Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, or Strongly Agree


  5. Incidence of ipsilateral breast and nodal recommendation and performance of biopsy based on breast imaging follow-up [ Time Frame: Up to 5 years ]
    Multivariable logistic regression analysis using generalized estimating equations to take the intra-patient correlation into account will be used to determine factors significantly associated with the outcome.

  6. Residual cancer burden (RCB) [ Time Frame: Up to 5 years ]
    Will be assessed by biopsy and routine surgery. Descriptive statistics will be used. The final biopsy will be compared with the response status determined by routine pathologic examination of surgery specimens using McNemar test.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed unicentric invasive breast cancer defined as radiologic clinical stage T1 or T2 (=< 5 cm), N0 or N1 (=< 4 abnormal axillary nodes on initial ultrasound), clinical stage M0
  • HER2 positive (immunohistochemistry [IHC] 3+ and or fluorescence in situ hybridization [FISH] amplified) or triple receptor negative (triple negative [TN], estrogen receptor [ER]/progesterone receptor [PR] < 10% HER2 negative [IHC 1+ or 2+ FISH non-amplified]) receiving any standard routine clinical NST regimen
  • Patient desires breast conserving therapy
  • Age 40 years or older; this age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of IBTR presumably due to underlying biologic differences
  • Female sex
  • If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer
  • Patient must have an initial nodal ultrasound that does not demonstrate more than four suspicious lymph nodes, any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present

Exclusion Criteria:

  • Radiologic evidence for a stage T3 or clinical stage T4 breast cancer
  • Clinical or pathologic evidence for distant metastases
  • Prior diagnosis of invasive or ductal carcinoma in situ breast cancer in the ipsilateral breast
  • Clinical evidence of progression of disease > 20% in the breast or new evidence of nodal metastases
  • Patient is known to be pregnant
  • Patient is participating in a NST protocol in which surgical excision of the breast and or lymph nodes are required

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945579


Contacts
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Contact: Henry Kuerer 713-745-5043 hkuerer@mdanderson.org

Locations
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United States, Arizona
Banner Health/Banner Research Not yet recruiting
Phoenix, Arizona, United States, 85006
Contact: Stephanie C. Byrum    480-256-6444    stephanie.byrum@bannerhealth.com   
Principal Investigator: Stephanie C. Byrum         
United States, Florida
Baptist MD Anderson Cancer Center Not yet recruiting
Jacksonville, Florida, United States, 32207
Contact: Beth A. Lesnikoski       beth.lesnikoski@hcahealthcare.com   
Principal Investigator: Beth A. Lesnikoski         
United States, Hawaii
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Clayton D. Chong    808-691-8777    clchong@queens.org   
Principal Investigator: Clayton D. Chong         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Judy C. Boughey    507-284-2511    boughey.judy@mayo.edu   
Principal Investigator: Judy C. Boughey         
United States, New Jersey
MD Anderson Cancer Center at Cooper-Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Catherine E. Loveland-Jones    856-135-6207    loveland-jones-catherine@CooperHealth.edu   
Principal Investigator: Catherine E. Loveland-Jones         
United States, North Carolina
Carolinas Medical Center/Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Richard L. White    980-442-6358    Richard.White@atriumhealth.org   
Principal Investigator: Richard L. White         
United States, Pennsylvania
University of Pittsburgh Cancer Institute (UPCI) Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Emilia J. Diego    412-641-3083    diegoe@upmc.edu   
Principal Investigator: Emilia J. Diego         
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Henry M. Kuerer    713-745-5043    hkuerer@mdanderson.org   
Principal Investigator: Henry M. Kuerer         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Henry M Kuerer M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02945579    
Other Study ID Numbers: 2016-0046
NCI-2016-01929 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0046 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases